TY - JOUR
T1 - Clinical outcomes of the ACURATE neo2 transcatheter heart valve
T2 - a prospective, multicentre, observational, post-market surveillance study
AU - Kim, Won-Keun
AU - Tamburino, Corrado
AU - Möllmann, Helge
AU - Montorfano, Matteo
AU - Ellert-Gregersen, Julia
AU - Rudolph, Tanja K
AU - Van Mieghem, Nicolas M
AU - Hilker, Michael
AU - Amat-Santos, Ignacio J
AU - Terkelsen, Christian Juhl
AU - Petronio, Anna Sonia
AU - Stella, Pieter R
AU - Götberg, Matthias
AU - Rück, Andreas
AU - Kasel, A Markus
AU - Trillo, Ramiro
AU - Appleby, Clare
AU - Barbanti, Marco
AU - Blanke, Philipp
AU - Modolo, Rodrigo
AU - Allocco, Dominic J
AU - Sondergaard, Lars
N1 - Funding Information:
The ACURATE neo2 PMCF Study was sponsored and funded by Boston Scientific Corporation (Marlborough, MA, USA). The data and study protocol for this clinical trial may be made available to other researchers in accordance with Boston Scientific’s data sharing policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).
Publisher Copyright:
© 2023 The authors.
PY - 2023/5
Y1 - 2023/5
N2 - Background: The next-generation ACURATE neo2 transcatheter aortic valve was designed for simplified implantation and to mitigate the risk of paravalvular leak (PVL) compared to the earlier device. Aims: We sought to collect clinical outcomes and device performance data, including echocardiography and 4-dimensional computed tomography (4D-CT) data, with the ACURATE neo2 transcatheter heart valve in patients with severe aortic stenosis (AS). Methods: The ACURATE neo2 Post-Market Clinical Follow-up (PMCF) Study is a single-arm, multicentre study of patients with severe AS treated in routine clinical practice. The primary safety endpoint was all-cause mortality at 30 days. The primary imaging endpoint was hypoattenuated leaflet thickening (HALT), measured by core laboratory-adjudicated 4D-CT at 30 days. Secondary endpoints included Valve Academic Research Consortium safety endpoints, procedural success, and evaluation of valve performance via core laboratory-adjudicated echocardiography. Results: The study enrolled 250 patients at 18 European centres (mean age: 80.8 years; 63.6% female; mean Society of Thoracic Surgeons score: 2.9±2.0%); 246 patients (98.4%) were successfully treated with the ACURATE neo2. The 30-day rates for mortality and disabling stroke were 0.8% and 0%, respectively. The new permanent pacemaker implantation rate was 6.5%. HALT >50% was present in 9.3% of patients at 30 days. Valve haemodynamics improved from baseline to 30 days (mean aortic valve gradient: from 47.6±14.5 mmHg to 8.6±3.9 mmHg; mean aortic valve area: from 0.7±0.2 cm2 to 1.6±0.4 cm2). At 30 days, PVL was evaluated as none/trace in 79.2% of patients, mild in 18.9%, moderate in 1.9%, and severe in 0%. Conclusions: The study results support the safety and efficacy of transcatheter aortic valve implantation with the ACURATE neo2 in patients in routine clinical practice.
AB - Background: The next-generation ACURATE neo2 transcatheter aortic valve was designed for simplified implantation and to mitigate the risk of paravalvular leak (PVL) compared to the earlier device. Aims: We sought to collect clinical outcomes and device performance data, including echocardiography and 4-dimensional computed tomography (4D-CT) data, with the ACURATE neo2 transcatheter heart valve in patients with severe aortic stenosis (AS). Methods: The ACURATE neo2 Post-Market Clinical Follow-up (PMCF) Study is a single-arm, multicentre study of patients with severe AS treated in routine clinical practice. The primary safety endpoint was all-cause mortality at 30 days. The primary imaging endpoint was hypoattenuated leaflet thickening (HALT), measured by core laboratory-adjudicated 4D-CT at 30 days. Secondary endpoints included Valve Academic Research Consortium safety endpoints, procedural success, and evaluation of valve performance via core laboratory-adjudicated echocardiography. Results: The study enrolled 250 patients at 18 European centres (mean age: 80.8 years; 63.6% female; mean Society of Thoracic Surgeons score: 2.9±2.0%); 246 patients (98.4%) were successfully treated with the ACURATE neo2. The 30-day rates for mortality and disabling stroke were 0.8% and 0%, respectively. The new permanent pacemaker implantation rate was 6.5%. HALT >50% was present in 9.3% of patients at 30 days. Valve haemodynamics improved from baseline to 30 days (mean aortic valve gradient: from 47.6±14.5 mmHg to 8.6±3.9 mmHg; mean aortic valve area: from 0.7±0.2 cm2 to 1.6±0.4 cm2). At 30 days, PVL was evaluated as none/trace in 79.2% of patients, mild in 18.9%, moderate in 1.9%, and severe in 0%. Conclusions: The study results support the safety and efficacy of transcatheter aortic valve implantation with the ACURATE neo2 in patients in routine clinical practice.
UR - http://www.scopus.com/inward/record.url?scp=85163439846&partnerID=8YFLogxK
U2 - 10.4244/EIJ-D-22-00914
DO - 10.4244/EIJ-D-22-00914
M3 - Article
C2 - 36440588
SN - 1774-024X
VL - 19
SP - 83
EP - 92
JO - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
JF - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
IS - 1
ER -